Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeter Caravan
About this trial
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).
Eligibility criteria
Qualifiers
Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on high-resolution computed tomography (HRCT) performed within 1 year to or at Visit 1.
Forced vital capacity (FVC) of >/= 45% and diffusing capacity of the lungs for carbon monoxide (DLCO) >/= 25% predicted on PFTs performed at Visit 1.
Disqualifiers
Current or prior exposure to FDA approved anti-fibrotic therapy.
Extent of emphysema greater than extent of fibrosis.
Pregnancy or plans to become pregnant at baseline or during follow-up.
Contraindications to MRI.
Trial design
Treatments tested in this trial
- [68Ga]CBP8
- Gadoterate Meglumine
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Peter Caravan
Lead sponsor
Massachusetts General Hospital
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov